Actively Recruiting

Phase Not Applicable
Age: 4Years - 6Years
All Genders
Healthy Volunteers
NCT06066983

DINO RCT - Treating Anxiety in Children With Autism

Led by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Updated on 2026-04-23

70

Participants Needed

1

Research Sites

145 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Anxiety is prevalent in young children, under 7 years of age, with autism. Yet, few studies have examined anxiety interventions for this age range, and only one anxiety treatment study has included young children with cognitive and language delays. Anxiety treatment models utilizing cognitive-behavioral therapy (CBT), adapted for children with autism, are empirically supported in school-age autistic children. Further, preliminary evidence suggests CBT approaches may reduce intolerance of uncertainty (IU), a mechanistic construct that may contribute to the maintenance of anxiety in autistic children. This study seeks to address the existing gap in anxiety treatment by examining the feasibility and preliminary efficacy of a novel, telehealth CBT intervention, DINO Strategies for Anxiety and intolerance of Uncertainty Reduction (DINOSAUR), which targets both anxiety and IU in young autistic children.

CONDITIONS

Official Title

DINO RCT - Treating Anxiety in Children With Autism

Who Can Participate

Age: 4Years - 6Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 4 years 0 months to 6 years 11 months
  • Diagnosed with autism spectrum disorder based on clinical impressions and ADOS-2 results
  • Anxiety problems with CBCL Anxiety T-score greater than 65
  • Cognitive ability score (SB-5 ABIQ) greater than 60
  • Receptive and expressive language age equivalent above 36 months based on TELD-4
  • Parent or caregiver available and willing to attend 14-week intervention
  • No identifiable neurological, genetic, or severe sensory-motor conditions
  • Able to walk independently (required for ADOS-2)
Not Eligible

You will not qualify if you...

  • Primary language other than English
  • Child is in foster care
  • Child has severe behavior challenges preventing participation (e.g., severe tantrums, aggression, self-injury)
  • Participating parent has active symptoms of substance abuse or severe mental illness (e.g., schizophrenia, bipolar disorder)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Kennedy Krieger Institute

Baltimore, Maryland, United States, 21211

Actively Recruiting

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Research Team

B

Belina Onomake

CONTACT

A

Amy Keefer, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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DINO RCT - Treating Anxiety in Children With Autism | DecenTrialz